
Sigma Chemical Co.
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GLUCOSE REAGENT SYS, SIGMA PROCED. 115 is an FDA 510(k)-cleared medical device (K760247) manufactured by Sigma Chemical Co.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 25, 1976. Regulation: 8.